This was a lecture in the course "Significant Medical Conditions in Seniors" presented at Peer Learning in Chapel Hill, NC, USA in 2016 by Michael C. Joseph, MD, MPH.
1.Patients have poor or no knowledge of the price variations among branded and generic medicines, and leave the choice of the medicine to the doctor.
2.The government must take up generic promotional schemes, general awareness programs on quality of generics to build confidence among prescribers, pharmacists, and consumers.
Hi
I am Rahul Ranjan Rai, perusing MBA from Jaypee Business School and I have completed this Project under the supervision of Pro. Evan Costle (france). I hope this presentation will help you to understand the emerging concepts in Generic Industry
Thank you
Regards
Rahul
1.Patients have poor or no knowledge of the price variations among branded and generic medicines, and leave the choice of the medicine to the doctor.
2.The government must take up generic promotional schemes, general awareness programs on quality of generics to build confidence among prescribers, pharmacists, and consumers.
Hi
I am Rahul Ranjan Rai, perusing MBA from Jaypee Business School and I have completed this Project under the supervision of Pro. Evan Costle (france). I hope this presentation will help you to understand the emerging concepts in Generic Industry
Thank you
Regards
Rahul
Generic Drugs having low cost. We should know about world drug scenario. In our daily life, we must concern with doctors and take drugs for cure. But we are not aware about drugs.We should know about drugs, not to become a Doctor, but for general awareness or at least to know what we are taking for our helth.
To my mind, the cost of healthcare as it appears, is to a large extent, exaggerated by "frills" of the pharmaceutical companies in:
1.Packaging & cartoning for retail use. 2. Brand promotion among physicians to get brand-loyalty for specific prescriptions.
3.Salaries of drug representatives in large numbers to achieve personal friendships with physicians and thereby modulating their prescriptions!
4. Printing of large amount of promotion literature to act as education & reminders.
5.Organising expensive travel to physicians to exotic locations to win their favour of loyal prescriptions as a return for memorable experiences.
6.Gifts and souvenirs with personalized inscriptions !
WHAT IS THE DIFFERENCE BETWEEN PCD, GENERIC, AND ETHICAL PHARMA SECTORS?ambitbiomedix12
DIFFERENCE BETWEEN PCD, GENERIC, AND ETHICAL PHARMA SECTORS. Read More: https://bit.ly/2GFIONg
Are you a little bit confused about the difference between PCD, Generic, and Ethical Pharma Sectors? This blog gives the required information concisely and precisely.
Website: http://ambitbiomedix.com/
Social Media:
Facebook - https://www.facebook.com/ambitbiomedix/?ref=settings
Instagram - https://www.instagram.com/ambit_bio_medix/
Twitter - https://twitter.com/ambitbiomedix?lang=en
Linkedin - https://www.linkedin.com/company/ambit%E2%84%A2-bio-medix/about/
Youtube - https://www.youtube.com/watch?v=GPzB82AjvQA&t=3s
Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...Michael Swit
Webinar sponsored by The Weinberg Group on Orphan Drugs, covering these topics:
The Basics of the Orphan Drug Act
Benefits of Orphan Drug status
Exclusivity
Protocol assistance, tax credits, and research grants
When is an indication is “rare”?
Orphan Drug Designation Requests – ensuring yours
robust and persuasive
Approval criteria for orphan products – how they
compare to non-orphan products
Challenges in the Orphan Drug Process
Generic medicines promulgating growth and access rev1Balaji Ramadurai
Large population of poor people in India, find it difficult to afford the more expensive branded category of medicines. They were fired up by our PM's “Jan Aushadhi” scheme which ensures availability of quality medicines at affordable prices to all.
My students are doing their bit for the country . Appreciate if you could look through their work and encourage them for their future. In case you need to contact them, we have provided the contacts on their project material.
Mastering Regulatory Approval in New Orphan Drug MarketsLewis Lau
Presented at DIA 2015 Annual Meeting. A symposum titled "A Global Update on Orphan Drug" chaired by Mr Noriaki Murao
http://www.diaglobal.org/en-US/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/Find-Sessions-and-Presentations/Event-Details.aspx?productID=3803687&eventType=Symposium&title=A%20Global%20Update%20on%20Orphan%20Drugs
This symposium addresses the current status and forthcoming activities related to orphan drugs in North America, EU and Japan. Orphan drug development is considered essential in these regions, and the various provisions to accelerate the development of orphan drugs have been implemented. However, some challenges still remain for the companies and the agencies wishing to pursue development and approval of orphan drugs in these regions.
The orphan drug area is relatively new but fast growing. Over the next weeks, Black Swan Consulting will summarise information on this class of drug products. Please also see http://black-swan-consulting.com/what-is-cooking/Orphan-drugs.
Generic Drugs having low cost. We should know about world drug scenario. In our daily life, we must concern with doctors and take drugs for cure. But we are not aware about drugs.We should know about drugs, not to become a Doctor, but for general awareness or at least to know what we are taking for our helth.
To my mind, the cost of healthcare as it appears, is to a large extent, exaggerated by "frills" of the pharmaceutical companies in:
1.Packaging & cartoning for retail use. 2. Brand promotion among physicians to get brand-loyalty for specific prescriptions.
3.Salaries of drug representatives in large numbers to achieve personal friendships with physicians and thereby modulating their prescriptions!
4. Printing of large amount of promotion literature to act as education & reminders.
5.Organising expensive travel to physicians to exotic locations to win their favour of loyal prescriptions as a return for memorable experiences.
6.Gifts and souvenirs with personalized inscriptions !
WHAT IS THE DIFFERENCE BETWEEN PCD, GENERIC, AND ETHICAL PHARMA SECTORS?ambitbiomedix12
DIFFERENCE BETWEEN PCD, GENERIC, AND ETHICAL PHARMA SECTORS. Read More: https://bit.ly/2GFIONg
Are you a little bit confused about the difference between PCD, Generic, and Ethical Pharma Sectors? This blog gives the required information concisely and precisely.
Website: http://ambitbiomedix.com/
Social Media:
Facebook - https://www.facebook.com/ambitbiomedix/?ref=settings
Instagram - https://www.instagram.com/ambit_bio_medix/
Twitter - https://twitter.com/ambitbiomedix?lang=en
Linkedin - https://www.linkedin.com/company/ambit%E2%84%A2-bio-medix/about/
Youtube - https://www.youtube.com/watch?v=GPzB82AjvQA&t=3s
Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...Michael Swit
Webinar sponsored by The Weinberg Group on Orphan Drugs, covering these topics:
The Basics of the Orphan Drug Act
Benefits of Orphan Drug status
Exclusivity
Protocol assistance, tax credits, and research grants
When is an indication is “rare”?
Orphan Drug Designation Requests – ensuring yours
robust and persuasive
Approval criteria for orphan products – how they
compare to non-orphan products
Challenges in the Orphan Drug Process
Generic medicines promulgating growth and access rev1Balaji Ramadurai
Large population of poor people in India, find it difficult to afford the more expensive branded category of medicines. They were fired up by our PM's “Jan Aushadhi” scheme which ensures availability of quality medicines at affordable prices to all.
My students are doing their bit for the country . Appreciate if you could look through their work and encourage them for their future. In case you need to contact them, we have provided the contacts on their project material.
Mastering Regulatory Approval in New Orphan Drug MarketsLewis Lau
Presented at DIA 2015 Annual Meeting. A symposum titled "A Global Update on Orphan Drug" chaired by Mr Noriaki Murao
http://www.diaglobal.org/en-US/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/Find-Sessions-and-Presentations/Event-Details.aspx?productID=3803687&eventType=Symposium&title=A%20Global%20Update%20on%20Orphan%20Drugs
This symposium addresses the current status and forthcoming activities related to orphan drugs in North America, EU and Japan. Orphan drug development is considered essential in these regions, and the various provisions to accelerate the development of orphan drugs have been implemented. However, some challenges still remain for the companies and the agencies wishing to pursue development and approval of orphan drugs in these regions.
The orphan drug area is relatively new but fast growing. Over the next weeks, Black Swan Consulting will summarise information on this class of drug products. Please also see http://black-swan-consulting.com/what-is-cooking/Orphan-drugs.
Qui Tam: Off Label Drug Marketing [Data Snapshot]lawsuitlegal
When does the promotion of a pharmaceutical become illegal?
Learn what is considered off-label use for popular drugs and when it becomes unlawful in this data snapshot.
We share the most common types of off-label uses, where it happens most often, and what exceptions provide 'safe haven' protection.
Most doctors and hospitals are prescribing doctors as they should be, with the patients in mind.
However, off-label prescriptions are important when considered in relation to the False Claims Act. The issue of insurance reimbursement takes center stage when drugs are being used unlawfully and these healthcare organizations are receiving insurance payments for improper use.
So take a moment to review the data with us on Off-Label Marketing relating to qui tam actions, today.
This was a lecture in the course "Significant Medical Conditions in Seniors" presented at Peer Learning in Chapel Hill, NC, USA in 2016 by Michael C. Joseph, MD, MPH.
This was a lecture in the course "Significant Medical Conditions in Seniors" presented at Peer Learning in Chapel Hill, NC, USA in 2016 by Michael C. Joseph, MD, MPH.
This was a lecture in the course "Significant Medical Conditions in Seniors" presented at Peer Learning in Chapel Hill, NC, USA in 2016 by Michael C. Joseph, MD, MPH.
This was a lecture in the course "Significant Medical Conditions in Seniors" presented at Peer Learning in Chapel Hill, NC, USA in 2016 by Michael C. Joseph, MD, MPH.
This was a lecture in the course "Significant Medical Conditions in Seniors" presented at Peer Learning in Chapel Hill, NC, USA in 2016 by Michael C. Joseph, MD, MPH.
This was a lecture in the course "Significant Medical Conditions in Seniors" presented at Peer Learning in Chapel Hill, NC, USA in 2016 by Michael C. Joseph, MD, MPH.
This was a lecture in the course "Significant Medical Conditions in Seniors" presented at Peer Learning in Chapel Hill, NC, USA in 2016 by Michael C. Joseph, MD, MPH.
This was a lecture in the course "Significant Medical Conditions in Seniors" presented at Peer Learning in Chapel Hill, NC, USA in 2016 by Michael C. Joseph, MD, MPH.
This was a lecture in the course "Significant Medical Conditions in Seniors" presented at Peer Learning in Chapel Hill, NC, USA in 2016 by Michael C. Joseph, MD, MPH.
This is the initial lecture in the course "Significant Medical Conditions in Seniors" presented at Peer Learning in Chapel Hill, NC, USA in 2016 by Michael C. Joseph, MD, MPH.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
Follow us on: Pinterest
Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
Telegram: bmksupplier
signal: +85264872720
threema: TUD4A6YC
You can contact me on Telegram or Threema
Communicate promptly and reply
Free of customs clearance, Double Clearance 100% pass delivery to USA, Canada, Spain, Germany, Netherland, Poland, Italy, Sweden, UK, Czech Republic, Australia, Mexico, Russia, Ukraine, Kazakhstan.Door to door service
Hot Selling Organic intermediates
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
Contact us if you are interested:
Email / Skype : kefaya1771@gmail.com
Threema: PXHY5PDH
New BATCH Ku !!! MUCH IN DEMAND FAST SALE EVERY BATCH HAPPY GOOD EFFECT BIG BATCH !
Contact me on Threema or skype to start big business!!
Hot-sale products:
NEW HOT EUTYLONE WHITE CRYSTAL!!
5cl-adba precursor (semi finished )
5cl-adba raw materials
ADBB precursor (semi finished )
ADBB raw materials
APVP powder
5fadb/4f-adb
Jwh018 / Jwh210
Eutylone crystal
Protonitazene (hydrochloride) CAS: 119276-01-6
Flubrotizolam CAS: 57801-95-3
Metonitazene CAS: 14680-51-4
Payment terms: Western Union,MoneyGram,Bitcoin or USDT.
Deliver Time: Usually 7-15days
Shipping method: FedEx, TNT, DHL,UPS etc.Our deliveries are 100% safe, fast, reliable and discreet.
Samples will be sent for your evaluation!If you are interested in, please contact me, let's talk details.
We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
3. Drug Development
Only 1 in 10,000 drugs studied makes it to
market
It takes more than 10 years of clinical studies
to bring a new drug to market
Each clinical study costs upwards of $15,000
per patient
Total drug development costs average $2.5B
Patents protect drugs from copycat versions
for 20 years after the drug is invented. This
includes the time spent in clinical studies to
accumulate enough data to get a drug
approved by the U.S. Food and Drug
Administration.
4. Prescription Drug Price Increases
U.S. prescription spending rose 12.2% in 2014, accelerating from a 2.4% rise in
2013.
From 2010-2015 there were price increases of 100% (insulin), 1,000% (skin
treatments), and 1,000% for heart medicines; all these drugs were > 10 years old.
The top 50 Branded drug price increases ranged from 63% to 391% (Edecrin®,
etacrynic acid, a diuretic) from December 2012 to July 2015.
Turing Pharmaceuticals bought and increased the price of an old anti-parasitic drug,
Daraprim®, from $ 3.50 per pill to $ 750.00 (5,000%). The Turing CEO, Martin
Shkreli, invoked the Fifth Amendment in a Congressional Hearing on Drug Prices,
then after being excused and leaving the room he promptly called the lawmakers
“imbeciles” on Twitter.
Mylan Pharmaceuticals raised the price of a two-pack of Epipen® (injectable
epinephrine) from $100 in 2009 to $608 in 2016. The two-pack costs around $60
to produce. [Mylan agreed to a recent $ 465 million settlement with the federal
government on allegations that it overcharged Medicaid for Epipen. (Wall Street
Journal, 28 October 2016] [Epipen costs $21 USD and is free to seniors in the U.K.
(Letter to the Editor, Wall Street Journal)]
5. TV Drug Advertising
Drugmakers spent $ 2.4 billion on TV ads for prescription
drugs in 2015, up 23 % from 2014.
TV audiences have grown accustomed to ads for treatment
for high cholesterol, erectile dysfunction, overactive
bladder, and a host of other “lifestyle” conditions.
Newer ads cover serious, life-threatening conditions or
those with relatively small populations – often expensive
medicines prescribed by specialist doctors, such as:
−Optivo® which costs about $12,500 per month (for lung
cancer)
−Hetlioz®, which costs $ 148,000 per year (for a sleeping
disorder that affects only about 80,000 blind people)
−Plus drugs for Multiple Sclerosis and Plaque Psoriasis.
6. The Cost-benefit Argument
In many European countries, the price of a new drug is a
condition of marketing approval
In the U.S., the price of a new drug is a marketing decision (what
the market will bear and competitors’ pricing) by the drug
company sponsor
In addition to recouping the cost of drug development, examples
of cost-benefit arguments by sponsors include:
− Treatment of Hepatitis C will save millions in 20-30 years by reduced
complications (liver cancer, cirrhosis) and costs (liver transplants). Solvadi®
costs $7,000 per week for 12 weeks ($ 84,000), but a 12-week regimen costs
only $136 to manufacture.
− The cost per lung cancer patient over the 5.7 month treatment period will be
more than $65,000 for Portrazza®, after studies showed survival for 11.5 months
vs. 9.9 months in patients treated with standard chemotherapy. Portrazza costs
$11,430/month, but the monthly cost should be only $1,875, according to
a cost-benefit analysis.
7. Generics Regulations
Generic Drugs must:
−contain the same active ingredients as the innovator (brand
name) drug (inactive ingredients may vary)
−be identical in strength, dosage form, and route of
administration
−have the same use indications
−be bioequivalent (match 80-125% of the blood level of the
brand name drug)
−meet the same batch requirements for identity, strength,
purity, and quality
−be manufactured under the same strict standards of FDA's
Good Manufacturing Practice regulations required for innovator
products.
(FDA 2009)
8. Generic Drugs Marketing
The first approved Generic is granted six
months’ marketing exclusivity.
In 2015, Generics accounted for 88% of new
prescriptions, but only 28% of total drug
spending.
They can cost up to 60-90% less than the
price of the brand-name drug, but they may
not be covered by insurers and may have
higher out-of-pocket costs.
9.
10. Generics Drug Pricing
A federal probe has been underway since 2014 into Generics price-
fixing.
The top 50 generic drug price increases ranged from 474%
(ethacrynic acid – an old diuretic) to over 18,000% (tetracycline – an
old antibiotic) from December 2012 to July 2015.
More than 300 of 1,441 Generics reviewed had at least one 100%
price increase between 2010 and 2015.
Large purchasers have sued Mylan and Endo after price increases of
884% (digoxin) and 8,281% (doxycycline – an old antibiotic for
multiply-resistant infections), between 2012 and 2014.
(Wall Street Journal, 04 November 2016)
11. Generics Marketing Delays
Drug companies can delay Generics by:
−extending the branded drug’s patent life;
−suing the Generics companies for patent
infringement (especially in biologics, where
unique production techniques are employed);
−paying a fee to the Generics companies to
delay their marketing;
−marketing “Authorized Generics”:
Either by licensing a Generics company; or
By safety and efficacy testing of old drugs, [e.g.
Colcrys® (colchicine)] and obtaining 3-year
exclusivity.
12. Anticompetitive Drug Pricing
Drug companies can stifle competition
by:
−buying both Patent-holding and Generics
companies;
−decreasing their tax burden by shifting
income abroad, through mergers or
purchases of foreign companies;
−extending their patent by 5 years through
a new dosage form or route of delivery,
changes to the active molecule (such as
isolating the L-form of Lexapro®), or
combining old Generics.
14. Narrow Therapeutic Index (NTI)
NTI drugs are those for which:
a) There is less than a 2-fold difference in
median Lethal dose and median Effective dose
values, or
b) There is less than a 2-fold difference in the
minimum Toxic concentration and minimum
Effective concentration in the blood, and
c) Safe and Effective use of the drug products
require careful Titration and Patient
Monitoring.
(US FDA, 2013).
15. Safety Problems with NTI Generics
Antidepressants
−A patient who is not responding to an
antidepressant may be prescribed an increased
dose or switched to another antidepressant or given
an additional antidepressant, as prescribers depend
on the therapeutic response for effective patient
management.
−The FDA approved a generic version of Wellbutrin
XL in 2006. Lack of efficacy complaints from
patients started. ConsumerLab used in vitro tests,
which showed that the generic version released
34% total of the active ingredient compared to the
brand name drug, and released only 8% in the
same length of time.
16. Safety Problems with NTI Generics
Antihypertensives
Decreased blood levels can cause hypertensive crisis
and stroke; increased blood levels can cause low
blood pressure, dizziness, fainting spells, and falls.
Of 35 Generics compared to Dilatrend®
(carvedilol), 3 had “incorrect mean carvedilol
content,” 1 had “excess impurities”, while 11 had
“incorrect hardness”, 9 “inadequate dissolution”, and
7 “failed two tests - generally hardness and
dissolution”.
17. Safety Problems with NTI Generics
Antiepileptics
Patients with uncontrolled epilepsy can have real social
and economic harm. They can be seriously injured during
a seizure, they can lose their right to drive, or even lose
their job.
−An Epilepsy Society of America survey of patients
who were switched to a Generic found:
59% reported a worsening of seizures
49% reported worsened side effects
Review of an Rx database showed:
◦ Patients who had an epileptic event requiring ER care,
and had not required care for at least 6 months - had
81% greater odds of having had a switch to a Generic.
18. Safety Problems with NTI Generics
Anticoagulants
−Anticoagulant drugs, such as warfarin, must
be dosed for each individual patient, and lab
tests must be monitored on a regular basis to
avoid serious adverse events of hemorrhage
with overdose, and clotting with underdose.
−This table shows Higher Risks from 37,756
switches between Coumadin® and warfarin.
Drug Thrombotic Events Hemorrhage Risk
Coumadin to warfarin 1.81x 1.51x
warfarin to Coumadin 1.76x 1.74x
warfarin to another
warfarin
1.89x 1.74x
19. Over-the-Counter (OTC) Drugs
Over-the-counter medicines (OTCs) or
nonprescription medicines refers to medicines that
you can buy without a prescription. They are safe and
effective when you follow the directions on the
label and as directed by your health care
professional.
They are marketed for self-limited conditions such as
pain, diarrhea, skin care, and cough and cold
symptoms. Their prices are generally low.
The treated illnesses should be acute, unlikely to
cause complications, and easy to diagnose (e.g.
vaginal yeast infections but not genital herpes).
Labeled directions recommend seeking medical care if
the patient is worried about worsening, new
symptoms, or the condition does not resolve within a
reasonable period.
20. Supplements - Background
It is not legal to market a supplement as a
preventive treatment, or cure, or to alleviate
the symptoms of a disease.
But, they are commonly used in illnesses
such as mood disorders, fatigue, pain,
insomnia, sexual dysfunction, and symptoms
of menopause.
They are used by 68% of adults, and more
than one-half of patients with cancer and
chronic illnesses – but 70% of users do not
inform their physicians.
21. Supplements - Regulation
Manufacturers do not have to get FDA’s approval
before producing or selling these products.
Dietary supplements do not have to prove safety
or the accuracy of their health claims before
approval for marketing.
Manufacturers and distributors are prohibited
from marketing products that are mislabeled or
adulterated.
Once on the market, supplements have the same
safety surveillance and reporting responsibilities
as mainstream (allopathic or homeopathic)
drugs.
22. Supplements - Labeling
Claims such as “Supports heart health” or
“Will help maintain your normal energy”
must be accompanied by this Disclaimer “This
statement has not been evaluated by the
Food and Drug Administration. This product
is not intended to diagnose, treat, cure, or
prevent any disease”.
Studies have shown that more than 90% of
supplement health claims are incorrect; 1/3 did
not contain the active ingredients claimed; and
1/3 contained unlisted substances – including
steroids, psychoactive substances, and toxic
substances such as arsenic, cadmium, lead, or
mercury.
23. Supplements – Safety Studies
Only 0.3% of the 55,000 dietary supplements on
the U.S. market have been studied regarding
their common side effects.
Randomized clinical studies of some antioxidants
and vitamins have found increased mortality
rates (iron in older women; beta-carotene in
patients with some cancers).
Supplements have been recalled because of:
−Microbiological, pesticide, or heavy metal contamination;
−Absence of a substance claimed to be in the product;
−The presence of more or less than the amount of the
main dietary ingredient listed on the label.
24. Supplements – Safety Risks
Supplements change the activity of
mainstream drugs by:
−Interference with binding to blood carrier proteins or target
tissues
−Competition for metabolic enzyme pathways, especially in
the liver;
−Increasing or decreasing clearance from the body
−Increasing or decreasing blood drug levels
These potential complications are especially critical for NTI
drugs or those with an inherent risk of toxicity – such as
cancer drugs, drugs for diabetes, and heart medications.
25. Senior Drug Safety Issues
Studies show that 40% of patients in their 60s
take more than five medications
(polypharmacy)
Medication use can increase from middle age for
patients being treated for chronic diseases such
as diabetes or cardiovascular disorders.
Patients may see multiple doctors who do not
coordinate their medications
Most drugs depend on intact liver and/or kidney
functions, which may be impaired, for proper
metabolism and clearance
Frailty, neurological changes, and nutritional
deficiencies may increase the risks and severity
of common side effects, such as dizziness
26. AGS Beers Criteria
The AGS Beers Criteria for Potentially
Inappropriate Medication Use is a list of
drug and drug classes maintained by the
American Geriatrics Society (AGS)
It is a dynamic registry of medications and
drug interactions where the risks may be
greater than their benefits for people aged 65
and older.
The list focuses on drugs for chronic use,
including Branded, Generics, and OTCs.
27. Beers Criteria - Examples
NSAIDs (to reduce pain and
inflammation)
◦ Can increase the risk of bleeding stomach ulcers. Can
also increase blood pressure, damage your kidneys, and
worsen heart failure.
MUSCLE RELAXANTS
◦ Can make you groggy and confused, increase your risk
of falls, and cause dry mouth, constipation, and
problems urinating.
ANTIHISTAMINES
◦ Can cause confusion, blurred vision, dry mouth,
constipation, and problems urinating.
28. Drug Safety Personal Guidelines
Maintain a list of all medications and dosages
you take, including OTCs and Supplements.
Take this list (and any questionable drug
allergies) with you to every healthcare
encounter.
Be vigilant about side effects, and report any
unusual signs or symptoms with new
medications promptly.
Check your medicine cabinet periodically, and
discard unused and expired medications
appropriately.